a study of edp-938 in non-hospitalized adults with rsv who are at high risk for complications.

Conditions: RSV Infection

Summary: this is a phase 2b, randomized, double-blind, placebo-controlled study of edp-938 administered orally for the treatment of non-hospitalized adult subjects with confirmed rsv infection who are at high risk for complications after rsv infection.


Eligibility criteria:
inclusion criteria: * at least one of the following conditions that predispose them to complications after rsv infection: 1. age ≥65 years 2. congestive heart failure (chf) 3. asthma 4. chronic obstructive pulmonary disease (copd) * the subject has a new onset of any of the following symptom(s) or worsening of pre-existing symptom(s) consistent with a respiratory tract infection no more than 72 hours prior to the administration of the first dose of study drug: feeling feverish, headache, neck pain, fatigue, loss of appetite, interrupted sleep, body aches, sore throat, nasal congestion, cough, cough with phlegm, wheezing, or short of breath. * the subject reports at least 2 of the following symptoms, one of which must be reported as at least 'moderate' severity: cough, cough with phlegm, wheezing, or short of breath * the subject has tested positive for rsv infection using a naat (polymerase chain reaction \[pcr\] or other) on a nasal/nasopharyngeal swab sample. * a woman of childbearing potential who is sexually active with a male must agree to use two effective methods of contraception from the date of screening until 30 days after her last dose of study drug. * a male subject who has not had a vasectomy and is sexually active with a woman of childbearing potential must agree to use effective contraception from the date of screening to 90 days after his last dose of study drug. exclusion criteria: * the subject has an anticipated need for hospitalization within 24 hours of signing the study icf * the subject receives systemic antiviral, antibacterial, antifungal, or antimycobacterial therapy within 7 days prior to signing the study icf * the subject has concomitant respiratory infections that are viral (other than rsv but including influenza), bacterial, or fungal, including systemic bacterial or fungal infections, within 7 days prior to signing the study icf * the subject has a sars-cov-2 test result that is positive within 28 days prior to signing the study icf * the subject has copd with spirometry results (obtained within 1 year prior to signing the study icf) fev1 ≤35% * the subject has a known positive human immunodeficiency virus infection, active hepatitis a virus infection, chronic hepatitis b virus infection, and/or current hepatitis c virus (hcv) infection; subjects with a history of hcv infection who have achieved a documented sustained virologic response 12 weeks after completion of hcv therapy may be enrolled. * the subject has any of the following cardiac conditions: any congenital heart disease, congenital long qt syndrome, or any clinical manifestation resulting in qt interval prolongation * the subject has immunocompromised status * the subject is living in institutional care or assisted living facility and is also receiving acute care management for any respiratory condition; note: independent living apartments are not considered institutional care or assisted living facility

Keywords: high risk, respiratory syncytial virus